Iadademstat + SBRT + Atezolizumab for Small Cell Lung Cancer
(TIARA Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores a new combination of treatments for individuals with small cell lung cancer (SCLC) that has recurred or persisted after initial chemotherapy. The researchers aim to determine the optimal dose of iadademstat, a drug under investigation, combined with atezolizumab, an immune-based therapy, to assess if this combination effectively controls the cancer. This trial suits those with SCLC that has not significantly progressed after platinum-based chemotherapy and who have at least one tumor suitable for targeting with stereotactic body radiation therapy (SBRT). As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new combination therapy.
Do I have to stop taking my current medications for the trial?
The trial protocol does not specify if you need to stop taking your current medications. However, certain medications like antidepressants with specific activity and systemic immunosuppressive medications are restricted. It's best to discuss your current medications with the trial team to ensure they don't conflict with the study requirements.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that the combination of iadademstat and atezolizumab is still under study for safety. In ongoing trials, researchers test this combination to determine the safest and most effective dose. The goal is to see if iadademstat can help control cancer for a longer time when used with atezolizumab.
Although detailed safety information is not yet available, the presence of iadademstat in a phase 1 trial indicates that scientists are still learning about its safety in humans. This phase primarily assesses how well people tolerate the treatment and what side effects might occur. Participants receive close monitoring to manage any side effects.
In summary, while scientists remain hopeful about the potential benefits, the safety of iadademstat combined with atezolizumab is still under investigation. Participants in these trials play a crucial role in determining how safe and effective this treatment might be.12345Why are researchers excited about this trial's treatments?
Iadademstat is unique because it targets a specific protein, LSD1, which is involved in the growth and spread of small cell lung cancer (SCLC). Unlike traditional chemotherapy that broadly attacks fast-growing cells, Iadademstat's precision can potentially lead to fewer side effects and more effective tumor control. Researchers are excited about this treatment because it can be combined with Atezolizumab, an immunotherapy drug, to enhance the body's immune response against cancer cells, offering a novel approach that could improve outcomes for patients with SCLC.
What evidence suggests that this trial's treatments could be effective for small cell lung cancer?
In this trial, participants will receive a combination of iadademstat and atezolizumab. Previous studies have shown that adding iadademstat to atezolizumab can stabilize cancer for longer periods compared to using atezolizumab alone. Iadademstat blocks LSD1, an enzyme necessary for cancer cell growth, which may enhance the effectiveness of immune treatments like atezolizumab. Early findings suggest that this combination could improve outcomes for patients with small cell lung cancer (SCLC). Although more research is needed, these early results are promising for treating SCLC.13567
Who Is on the Research Team?
Annie Chiang, MD
Principal Investigator
Yale University
Are You a Good Fit for This Trial?
This trial is for people with a certain type of lung cancer (ES-SCLC) that's come back or hasn't gone away after platinum-based chemo. It's also open to those who've had stable disease post initial treatment, even if they've tried immune checkpoint inhibitors before.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Dose Escalation and Treatment
Participants receive iadademstat combined with atezolizumab and SBRT. Dose escalation and de-escalation will be guided by the BOIN design.
Maintenance Therapy
Participants receive maintenance therapy with iadademstat and atezolizumab after initial treatment phase.
Follow-up
Participants are monitored for safety and effectiveness after treatment. Includes survival follow-up visit 30 days post end of treatment.
What Are the Treatments Tested in This Trial?
Interventions
- Atezolizumab
- Iadademstat
- SBRT
Trial Overview
The study tests Iadademstat combined with SBRT (a targeted radiation therapy) and Atezolizumab, an immunotherapy drug. Since it's phase 1b, the focus is on finding the right dose of Iadademstat that’s safe when given with SBRT and Atezolizumab.
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
The first three participants will start iadademstat at a dose of 600ug PO weekly (DL 1). Dose escalation and de-escalation will be guided by the BOIN design. Dose finding will continue until the pre-specified sample size of 15 is reached or stop the trial if the number of participants treated at the current dose reaches 12 and the decision is to stay at the current dose. Atezolizumab will be administered by intravenous (IV) infusion at a fixed dose of 1680mg on Day 1 of each 28-day cycle until unacceptable toxicity or loss of clinical benefit as determined by the treating investigator after an integrated assessment of radiographic and biochemical data, local biopsy results (if available), and clinical status (e.g., symptomatic deterioration such as pain secondary to disease).
Find a Clinic Near You
Who Is Running the Clinical Trial?
Yale University
Lead Sponsor
Genentech, Inc.
Industry Sponsor
Ashley Magargee
Genentech, Inc.
Chief Executive Officer since 2024
MBA from Harvard University, BA from Princeton University
Levi Garraway
Genentech, Inc.
Chief Medical Officer since 2021
MD, PhD
Oryzon Genomics S.A.
Industry Sponsor
Citations
NCT06287775 | Testing the Combination of an Anti-cancer ...
Adding iadademstat to either atezolizumab or durvalumab may be able to stabilize cancer for longer than atezolizumab or durvalumab alone in treating patients ...
Testing the Combination of an Anti-cancer Drug ...
Adding iadademstat to either atezolizumab or durvalumab may be able to stabilize cancer for longer than atezolizumab or durvalumab alone in treating patients ...
3.
oryzon.com
oryzon.com/en/news-events/news/oryzon-announces-first-patient-dosed-nci-sponsored-phase-iii-clinical-trialORYZON announces first patient dosed in NCI-sponsored ...
The first patient has been dosed in a Phase I/II trial of iadademstat, Oryzon's potent and selective LSD1 inhibitor, in combination with immune checkpoint ...
4.
clinicaltrialvanguard.com
clinicaltrialvanguard.com/news/oryzon-doses-first-patient-in-iadademstat-trial-in-small-cell-lung-cancer/Oryzon Doses First Patient in iadademstat Trial in Small ...
Positive results could significantly alter the treatment landscape for SCLC and potentially pave the way for accelerated regulatory pathways.
NCT07113691 | Iadademstat + SBRT With Atezo in ES-SCLC
The primary objective is evaluating the safety, tolerability and efficacy of iadademstat combined with atezolizumab and SBRT followed by ...
CLINICAL TRIAL / NCT06287775
This phase I/II trial tests the safety, side effects, and best dose of iadademstat when given together with atezolizumab or durvalumab.
Testing the Combination of an Anti-cancer Drug ...
Adding iadademstat to either atezolizumab or durvalumab may be able to stabilize cancer for longer than atezolizumab or durvalumab alone in ...
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